Hip Arthropathy
Conditions
Brief summary
This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.
Detailed description
Twenty participants with symptomatic primary total hip arthroplasty will be imaged with both methods. The results of the two methods will be compared in reference to the size of the artifact-degraded regions, visibility of the normal structures and the rate of abnormality detection.Primary Objective: To assess the size of the artifact-degraded regions, defined as regions of the image where underlying anatomic structure are obscured, between modified and standard MRI protocols. Secondary Objectives: (1) To assess the visibility of normal structures between modified and standard MRI protocols. (2) To assess the abnormality detection rate using modified and standard MRI protocols.
Interventions
DEVICEModified MRI
A technical modification to the standard MRI which only affects radiofrequency pulse polarization attempting to optimize the image quality. All other factors, including pulse sequence parameters, and patient and coil positioning is similar to that of the standard MRI.
Sponsors
NYU Langone Health
Radiological Society of North America
ISS, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 with unilateral symptomatic (e.g. pain) total hip arthroplasty * Referred for MRI examination at the discretion of the treating physician * Provision of signed and dated informed consent form * No metal hardware in the body including contralateral hip arthroplasty * No contraindication to MRI: defined as claustrophobia or presence of other MRI-incompatible devices
Exclusion criteria
* History of revision hip arthroplasty * Pregnancy (self-reported, or self-suspected) * Hip arthroplasty surgery within one year of enrollment * Clinical indication to administer intravenous contrast material during MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the size of the artifact-degraded regions | Visit 1, Day 0 | The area of artifact degraded regions (in pixel\^2) in paired images of modified and standard MRIs determined by manual segmentation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the visibility of normal structures | Visit 1, Day 0 | Visibility of anatomic landmarks (hip flexor, external rotator and abductor tendon attachments, joint capsule and implant-bone interface) on paired images of modified and standard MRIs using a 3-point scale with 1=structure visible without artifacts, 2=structure partly visible because of artifacts and 3=structure not visible because of artifacts |
| Assessment of the abnormality detection rate | Visit 1, Day 0 | Presence or absence of abnormality in paired images of modified and standard MRIs. Abnormalities include: bone marrow edema (defined as osseous short-tau inversion recovery (STIR) signal hyperintensity); fractures (linear osseous signal abnormality and osseous STIR signal hyperintensity); osteolysis (interposing linear or geographic signal hyperintensity between the host bone marrow and the implant surface); synovitis (capsular thickening and/or joint fluid with bulging of the capsule); tendinopathy (at least partial-thickness substance loss of the cross-sectional tendon area and/or split); extracapsular collections. |
Countries
United States
Contacts
CONTACTIman Khodarahmi, MD
PRINCIPAL_INVESTIGATORIman Khodarahmi, MD
NYU Langone Health
Outcome results
None listed